Director Clinical Development | Mediziner (m/w/d)
BioNTech SE
Job Summary
This pivotal role as Director of Clinical Development involves collaborating closely with the VP Clinical Development to shape and execute clinical strategies for programs and trials. The successful candidate will be responsible for the design and execution of clinical trials from early to late-stage development, leading matrix teams, and ensuring thorough data interpretation based on deep scientific, disease biology, and medical knowledge, including patient safety and data integrity. Day-to-day responsibilities include managing clinical activities, overseeing data review, and communicating with investigators. This position is ideal for a medical professional with a strong background in Immuno-Oncology, Oncology, or Infectious Diseases, looking to drive innovative clinical programs towards regulatory approval.
Required Skills
Education
M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology and/or Infectious diseases.
Experience
- Several years of relevant experience in immuno-oncology, oncology and/or infectious diseases in a biotech/pharmaceutical and/or academic environment
- Leadership of clinical development activities
- Experience from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA submission (ideally)
- Good understanding of clinical and scientific methods and approaches used in clinical development, from FIH to registration
- Hands-on experience in managing the day-to-day clinical operations for the successful conduct of clinical trials
- Experience in liaising with clinical operations and epidemiology
- Experience in preparing and conducting interactions with global health authorities (e.g., EMA, FDA)
- Strong experience in monitoring and interpreting safety and efficacy clinical trial data
- Experience ensuring appropriate liaison for trial medical and patient safety issues
- Functional and/or disciplinary leadership experience with a proven track record of leading teams (plus)
Languages
Additional
- Not specified
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